FDA: Page 69
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Key EU notified body meeting goes on, virtually
A Medical Device Coordination Group meeting, parts of which are postponed, comes as Germany, home to four of 11 notified bodies designated under EU MDR, anticipates widespread COVID-19 transmission.
By Nick Paul Taylor , Maria Rachal • March 11, 2020 -
Coronavirus spread prompts FDA to postpone nearly all overseas inspections
The agency based the decision on U.S. government travel restrictions and advisories, saying "alternative tools and methods" will help maintain oversight.
By Jonathan Gardner • March 10, 2020 -
Explore the Trendline➔
Sara Silbiger via Getty Images
TrendlineTop 5 stories from MedTech Dive
From haphazard layoffs at the Food and Drug Administration to the industry’s current IPO environment and tracking FDA-authorized AI devices, here is a collection of top stories from MedTech Dive.
By MedTech Dive staff -
Jacob Bell/MedTech Dive
FDA updates guidance on 510(k) submissions for electrosurgical devices
The agency offered greater detail on testing requirements in assessing thermal tissue damage.
By Susan Kelly • March 10, 2020 -
National Institute of Allergy and Infectious Diseases. (2020). "Novel coronavirus SARS-CoV-2" [Microscope image]. Retrieved from https://www.flickr.com/photos/nihgov/49535193876/in/album-72157713108522106/.
Labs step up capacity to meet demand for nationwide coronavirus testing
The Trump administration is relying on the "enormous capacity" of commercial labs to enable wide availability of COVID-19 diagnostic testing to the American public through physicians offices and pharmacies.
By Greg Slabodkin • March 10, 2020 -
Alex Wong via Getty Images
Long-awaited interoperability rules finalized by Trump admin, prompt industry ire
Providers and entrenched health IT interests are unlikely to be happy with the final iterations, which largely mirror the proposed versions. One win: The timeline to come into compliance has been pushed back.
By Rebecca Pifer • March 9, 2020 -
CDC/Alissa Eckert, MS. "covid-19 coronavirus on black background". Retrieved from https://www.cdc.gov/media/subtopic/images.htm.
ACC 2020 meeting canceled as coronavirus spreads in US
Abbott, Edwards and Medtronic were among the medtechs slated to present data at the American College of Cardiology's annual event. "This is a unique time for us all," the organization wrote in a statement Monday.
By Maria Rachal • March 9, 2020 -
Cardiologist groups back Abbott push to change heart device coverage
Some feedback to CMS supports a retreat from potentially restrictive terms used with ventricular assist devices. Responses to SynCardia’s separate bid to permit the use of artificial hearts outside of clinical trials were more mixed.
By Nick Paul Taylor • March 6, 2020 -
CDC/Alissa Eckert, MS. "covid-19 coronavirus on black background". Retrieved from https://www.cdc.gov/media/subtopic/images.htm.
$8.3B in coronavirus funding set in motion as federal agencies ramp up response
The House and Senate passed a bill with allocations for medical supplies and testing as Vice President Mike Pence met with clinical lab execs Wednesday from LabCorp, Quest Diagnostics, Thermo Fisher and others.
By Shannon Muchmore • Updated March 5, 2020 -
UK looks to use Brexit to make device industry more transparent
The House of Commons bill seeks to address a regulatory gap for medical devices, as the previous legal framework is based on EU directives. One element provides new information-sharing powers related to safety.
By Nick Paul Taylor • March 5, 2020 -
Some pacemakers, EKGs, diabetes devices may face newly flagged Bluetooth cyber risk
FDA and the Department of Homeland Security said microchips from seven manufacturers and a range of consumer wearables and connected medical devices may be affected.
By Susan Kelly • March 4, 2020 -
FDA bans certain electrical stimulation devices called 'barbaric'
Amid mounting pressure from lawmakers, the agency handed down its third-ever medical device ban, finalizing a 2016 proposal prohibiting current and future sale of certain devices to treat self-injury or aggressive behavior.
By Maria Rachal • March 4, 2020 -
E.A. Crunden/MedTech Dive
AdvaMed, Medtronic among top 20 pharma and health product lobbyists over 2 decades: study
The medical devices trade association spent $79.4 million on lobbying from 1999 to 2018, making it the fifteenth biggest spender.
By Nick Paul Taylor • March 3, 2020 -
Jacob Bell/MedTech Dive
Olympus-backed Medi-Tate gets FDA nod for prostate device
The Japanese corporation has an option to buy the Israeli startup and its newly De Novo-authorized benign prostatic hyperplasia device.
By Nick Paul Taylor • March 3, 2020 -
Supreme Court to again decide fate of ACA
The high court said Monday it would hear the case that seeks to overturn the Affordable Care Act pushed by Texas and other red-leaning states.
By Samantha Liss • Updated March 2, 2020 -
FDA seeks 'right balance' as it permits immediate use of coronavirus tests
"We are not changing our standards for issuing Emergency Use Authorizations," Commissioner Stephen Hahn said Saturday as the agency issued new guidance aimed at accelerating testing capacity in the U.S.
By Susan Kelly • March 2, 2020 -
Courtesy of Centers for Disease Control and Prevention
Coronavirus: No US shortages of essential devices yet, as FDA monitors more than 60 companies
Still, manufacturers operating 72 plants in China face workforce pressures and surging demand for some equipment, FDA said in an update late Thursday.
By Nick Paul Taylor • Feb. 28, 2020 -
California's new cybersecurity law sidesteps most medical devices, lawyers say
How the state enforces its "internet of things" or connected devices law "may end up becoming a source of persuasive authority for the FDA in its decision making" on cybersecurity guidance, said White and Williams' Joshua Mooney.
By Fred Donovan • Feb. 28, 2020 -
FDA posts trio of medical device warning letters
An apparent flurry of enforcement activity disclosed this week comes shortly after the agency signaled a return to greater vigilance following a nearly 90% decline in device-related warning letters from 2015 to 2019.
By Nick Paul Taylor • Feb. 28, 2020 -
Joint FDA, industry real-world evidence center issues research frameworks
As real-world evidence gains momentum as a tool for assessing medical device safety and effectiveness, NESTcc is laying out guiding principles on research methods and ensuring data quality.
By Amritpal Sandhu-Longoria • Feb. 27, 2020 -
FDA pilots new 510(k) submission template for device manufacturers
The voluntary assessment will enroll up to nine participants that reflect the makeup of the medical device industry.
By Nick Paul Taylor • Feb. 27, 2020 -
FDA advises boxed warning for surgical devices half-decade after flagging cancer risk to women
In 2014, FDA warned against the use of laparoscopic power morcellators for hysterectomy or fibroid removal for most women, after determining through its own data analysis that the devices could spread cancerous tissue.
By Susan Kelly • Feb. 26, 2020 -
HHS officials warn of medical supply shortages amid coronavirus outbreak
"This is an unprecedented potential severe health challenge globally, and will require additional measures," HHS Secretary Alex Azar told lawmakers in a pitch for $2.5 billion in funding.
By Amritpal Sandhu-Longoria • Feb. 26, 2020 -
LivaNova gets nod for heater-cooler device changes to cut contamination risk
At the same time, FDA updated its safety guidance for healthcare providers to reduce infection risk during open heart surgery.
By Nick Paul Taylor • Feb. 26, 2020 -
FDA bolsters CLIA waiver application recommendations
The agency added new sections on failure alerts, labeling and safeguards, doubling the length of a guidance text for in vitro diagnostic manufacturers in the process.
By Nick Paul Taylor • Feb. 26, 2020 -
On FDA's agenda: ortho reclassifications, cancer tests, AI in imaging
The agency scheduled an orthopaedic devices advisory panel for April to consider down-classing noninvasive bone growth stimulation systems. On Tuesday, a meeting on artificial intelligence in radiological imaging kicks off.
By Susan Kelly • Feb. 24, 2020
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